FDA to "review the latest data" on mifepristone. What could it mean for access to the abortion pill?

CBS News

2 days ago

Health and Human Services Secretary Robert F. Kennedy Jr. has asked Food and Drug Administration Commissioner Marty Makary "to review the latest data on mifepristone," raising questions about the drug commonly referred to as the abortion pill.
A spokesperson for the FDA confirmed the plans in a statement to CBS News Tuesday, but did not respond to questions about when the review is scheduled to start and what exactly it will be reviewing about the medication.
According to a letter published on social media Monday by Republican Sen. Josh Hawley of Missouri, Makary's review aims to closely monitor the drug's safety. But experts say concerns about its safety are misguided, fueled in part by a report from the Ethics and Public Policy Center, an advocacy group that promotes religious traditions and is funded by multiple right-wing organizations.
Mifepristone, which is taken with a second drug, misoprostol, to end an early pregnancy, was first approved by the FDA in 2000 after "a thorough and comprehensive review" determined it was safe and effective, the agency says. Periodic reviews since its approval have not found new safety concerns, according to the FDA.
In the Ethics and Public Policy Center report, which was not published in a peer-reviewed scientific journal, the authors, who don't have medical training, claim the pill harms women, causing 1 in 10 patients to experience what they call a "serious adverse event," including hemorrhage, ER visits, ectopic pregnancy and an undefined category of "abortion-specific complications."
Dr. Céline Gounder, CBS News medical contributor and editor-at-large for public health at KFF Health News, said some of the instances described as "adverse events" are questionable.
"When you have a medication abortion, you bleed. That is normal. That is not an adverse event unless the bleeding is so significant that a woman needs a transfusion," she explained. "It is to be expected that not all medication abortions will successfully eliminate the pregnancy. A surgical abortion after incomplete/failed medication abortion should not be considered an adverse event. ... An ectopic pregnancy is not caused by mifepristone and should not be considered a serious adverse event."
Gounder added that the report lacks transparency and doesn't disclose the data source, meaning no one can reproduce and verify the findings, something Kennedy himself said he's a proponent of, noting in his confirmation hearings that he wants to replicate studies.
It also lacks a comparison group, Gounder said, which is important for examining how experiences compare to pregnant women who did not take the drug.
CBS News has reached out to the makers of the generic and brand name of mifepristone for comment.
While it's unclear whether the latest review of the drug will impact access, this isn't the first time it has come under fire.
In 2024, the Supreme Court rejected a challenge targeting the availability of the widely used pill, preserving access to the drug in its first major abortion-related ruling since the reversal of Roe v. Wade. If the challengers had prevailed, the ruling would have restricted access to mifepristone nationwide, even in states where abortion is legal.
The justices unanimously ruled that the anti-abortion rights doctors and medical associations who brought the lawsuit against the FDA did not have the legal right to do so. They did not address whether the FDA acted lawfully when it took a series of steps in 2016 and 2021 that relaxed the rules for mifepristone's use.
Makary had previously said that he had "no plans to take action on mifepristone," which has been a target of abortion opponents and conservatives who have called on the FDA to reconsider its approval.
Since it was approved, mifepristone has been taken by more than 5 million patients, according to the FDA. Medication abortions made up more than half of all abortions in the United States health care system in 2023, a study from the Guttmacher Institute, an abortion rights research group, found.
In 28 states, there are policies restricting access to mifepristone in some way, according to the Guttmacher Institute, four of which prohibit the mailing of abortion pills to patients.
and contributed to this report.